Although the Food Safety Modernization Act (FSMA) was signed into law in January 2011, revisions to many of the regulations delayed their implementation. Recently, the FDA established several of the final rules for compliance and activated them in August and October 2015. These include preventive controls for human food and animal feed, produce safety, Foreign Supplier Verification Program (FSVP), and third-party accreditation and certification. Compliance with the regulations is required within 18 months to two and a half years depending on the specific regulation. But what do FDA auditors really expect to see when they visit your business?
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The FDA’s primary concern is ensuring that companies are following the regulations and therefore sends auditors to inspect the compliance records that companies keep, or may soon have to start keeping. The records demonstrate that the requisite steps were taken to meet compliance with the regulations. With regard to identification of contaminants, some food manufacturers may have to significantly augment their practices. Specifically, greater use of forensic or investigational analysis will be required. For example, food companies that obtain any portion of their product from outside of the U.S., whether whole or ingredients, will be subject to FSVP regulations. FSVP regulations require companies to investigate the origin of contaminants that may occur in their product. Under FSVP, the FDA will want to see the records for all stages of testing, including establishing the origin of contaminants. Although bulk analyses are great at establishing the presence of contaminants, bulk methods are not particularly good at identifying the what, when, and where of contamination; answering these questions typically requires forensic or investigational analysis methods. Maintaining the records from all stages of the investigation is vital for a successful positive outcome FDA audit.
Investigational Analysis: A New Paradigm
In the past, investigational analysis was not usually necessary in the food industry; the accepted norm was that most food ingredients were generally recognized as safe (GRAS). Establishing the provenance of contaminants can be costly, so firms typically limited investigational or forensic analysis to special cases, such as spices, where the product consists of a single, relatively high-priced ingredient, making the cost of analysis worthwhile. Alternatively, for some foods like spices, it was cheaper for large companies to simply buy or deal with source suppliers directly, removing middlemen and any incentive for economically motivated adulteration. However, the entire product processing path presents opportunities for contamination; both intentional and unintentional.
Enactment of FSMA and especially the FSVP now requires the food industry to provide more assurance and ultimately conduct more testing. The objective is no longer to simply identify contaminants but to understand and document how they ended up in the product. Additionally, records need to indicate and document who conducted the work during all stages of the identification.
To minimize the possibility of bias, the investigational analyses are best conducted, or corroborated, by an independent laboratory. The pharmaceutical industry has been subject to these types of regulations for years. This paradigm, although new to the food industry, brings positive advantages. For example, investigational analysis can provide greater confidence for establishing that a GRAS ingredient is safe even though a contaminant might be present. A food processor can remove certain contaminants, or prevent further contamination, once it understands how the contaminants manifest themselves in the product. Investigative analysis provides the pieces to the forensic contamination puzzle.
Investigational Analysis and Multiple Microscopy Methods
Any instance of product contamination or product failure can be traced to discreet particles or residues that may not be clearly visible or discernable to the naked eye. The size of contaminant particles can range from millimeters down to nanometers. Bulk analytical methods may identify the presence of a contaminant at trace or ultra trace concentrations, however they may not be of much use in identifying how that element came to be part of the product. Isolating the contaminants from the host product, on the other hand, allows for successful identification of the contaminants.